Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution Recalled by Pine Pharmaceuticals, LLC Due to Lack of Assurance of Sterility

Date: July 27, 2022
Company: Pine Pharmaceuticals, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Pine Pharmaceuticals, LLC directly.

Affected Products

Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY 14150.

Quantity: a) 920 syringes; b) 3263 syringes

Why Was This Recalled?

Lack of Assurance of Sterility

Where Was This Sold?

This product was distributed to 4 states: AL, CA, NY, NC

Affected (4 states)Not affected

About Pine Pharmaceuticals, LLC

Pine Pharmaceuticals, LLC has 24 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report